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How individual participant data meta-analyses have influenced trial design, conduct, and analysis.

Identifieur interne : 002741 ( PubMed/Corpus ); précédent : 002740; suivant : 002742

How individual participant data meta-analyses have influenced trial design, conduct, and analysis.

Auteurs : Jayne F. Tierney ; Jean-Pierre Pignon ; Francois Gueffyier ; Mike Clarke ; Lisa Askie ; Claire L. Vale ; Sarah Burdett

Source :

RBID : pubmed:26186982

English descriptors

Abstract

To demonstrate how individual participant data (IPD) meta-analyses have impacted directly on the design and conduct of trials and highlight other advantages IPD might offer.

DOI: 10.1016/j.jclinepi.2015.05.024
PubMed: 26186982

Links to Exploration step

pubmed:26186982

Le document en format XML

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<nlm:affiliation>MRC Clinical Trials Unit at UCL, Aviation House, 125 Kingsway, London WC2B 6NH, UK. Electronic address: jayne.tierney@ucl.ac.uk.</nlm:affiliation>
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<name sortKey="Pignon, Jean Pierre" sort="Pignon, Jean Pierre" uniqKey="Pignon J" first="Jean-Pierre" last="Pignon">Jean-Pierre Pignon</name>
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<name sortKey="Gueffyier, Francois" sort="Gueffyier, Francois" uniqKey="Gueffyier F" first="Francois" last="Gueffyier">Francois Gueffyier</name>
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<nlm:affiliation>Université Claude Bernard Lyon 1/Université de Lyon, 69365 Lyon Cedex 07, Lyon, France; Service de Pharmacologie Clinique, Hospices Civils de Lyon, Bron cedex, France.</nlm:affiliation>
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<name sortKey="Clarke, Mike" sort="Clarke, Mike" uniqKey="Clarke M" first="Mike" last="Clarke">Mike Clarke</name>
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<nlm:affiliation>All-Ireland Hub for Trials Methodology Research, Queen's University Belfast, University Road, Belfast BT7 1NN, Northern Ireland, UK.</nlm:affiliation>
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<name sortKey="Askie, Lisa" sort="Askie, Lisa" uniqKey="Askie L" first="Lisa" last="Askie">Lisa Askie</name>
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<name sortKey="Pignon, Jean Pierre" sort="Pignon, Jean Pierre" uniqKey="Pignon J" first="Jean-Pierre" last="Pignon">Jean-Pierre Pignon</name>
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<nlm:affiliation>LNCC plateforme de méta-analyse en oncologie, Service de Biostatistique et d'Epidemiologie, Gustave-Roussy, Villejuif, France.</nlm:affiliation>
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<name sortKey="Gueffyier, Francois" sort="Gueffyier, Francois" uniqKey="Gueffyier F" first="Francois" last="Gueffyier">Francois Gueffyier</name>
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<nlm:affiliation>Université Claude Bernard Lyon 1/Université de Lyon, 69365 Lyon Cedex 07, Lyon, France; Service de Pharmacologie Clinique, Hospices Civils de Lyon, Bron cedex, France.</nlm:affiliation>
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<name sortKey="Clarke, Mike" sort="Clarke, Mike" uniqKey="Clarke M" first="Mike" last="Clarke">Mike Clarke</name>
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<nlm:affiliation>All-Ireland Hub for Trials Methodology Research, Queen's University Belfast, University Road, Belfast BT7 1NN, Northern Ireland, UK.</nlm:affiliation>
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<name sortKey="Askie, Lisa" sort="Askie, Lisa" uniqKey="Askie L" first="Lisa" last="Askie">Lisa Askie</name>
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<nlm:affiliation>NHMRC Clinical Trials Centre, ABN 15 211 513 464, Locked Bag 77, Camperdown, NSW 1450 Australia.</nlm:affiliation>
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<name sortKey="Vale, Claire L" sort="Vale, Claire L" uniqKey="Vale C" first="Claire L" last="Vale">Claire L. Vale</name>
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<nlm:affiliation>MRC Clinical Trials Unit at UCL, Aviation House, 125 Kingsway, London WC2B 6NH, UK.</nlm:affiliation>
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<name sortKey="Burdett, Sarah" sort="Burdett, Sarah" uniqKey="Burdett S" first="Sarah" last="Burdett">Sarah Burdett</name>
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<nlm:affiliation>MRC Clinical Trials Unit at UCL, Aviation House, 125 Kingsway, London WC2B 6NH, UK.</nlm:affiliation>
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<title level="j">Journal of clinical epidemiology</title>
<idno type="eISSN">1878-5921</idno>
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<date when="2015" type="published">2015</date>
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<term>Clinical Trials as Topic (methods)</term>
<term>Humans</term>
<term>Meta-Analysis as Topic</term>
<term>Research Design</term>
<term>Research Subjects</term>
<term>Statistics as Topic</term>
</keywords>
<keywords scheme="MESH" qualifier="methods" xml:lang="en">
<term>Clinical Trials as Topic</term>
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<keywords scheme="MESH" xml:lang="en">
<term>Humans</term>
<term>Meta-Analysis as Topic</term>
<term>Research Design</term>
<term>Research Subjects</term>
<term>Statistics as Topic</term>
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<front>
<div type="abstract" xml:lang="en">To demonstrate how individual participant data (IPD) meta-analyses have impacted directly on the design and conduct of trials and highlight other advantages IPD might offer.</div>
</front>
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<PMID Version="1">26186982</PMID>
<DateCreated>
<Year>2015</Year>
<Month>10</Month>
<Day>28</Day>
</DateCreated>
<DateCompleted>
<Year>2016</Year>
<Month>02</Month>
<Day>04</Day>
</DateCompleted>
<DateRevised>
<Year>2017</Year>
<Month>09</Month>
<Day>22</Day>
</DateRevised>
<Article PubModel="Print-Electronic">
<Journal>
<ISSN IssnType="Electronic">1878-5921</ISSN>
<JournalIssue CitedMedium="Internet">
<Volume>68</Volume>
<Issue>11</Issue>
<PubDate>
<Year>2015</Year>
<Month>Nov</Month>
</PubDate>
</JournalIssue>
<Title>Journal of clinical epidemiology</Title>
<ISOAbbreviation>J Clin Epidemiol</ISOAbbreviation>
</Journal>
<ArticleTitle>How individual participant data meta-analyses have influenced trial design, conduct, and analysis.</ArticleTitle>
<Pagination>
<MedlinePgn>1325-35</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.1016/j.jclinepi.2015.05.024</ELocationID>
<ELocationID EIdType="pii" ValidYN="Y">S0895-4356(15)00268-1</ELocationID>
<Abstract>
<AbstractText Label="OBJECTIVES" NlmCategory="OBJECTIVE">To demonstrate how individual participant data (IPD) meta-analyses have impacted directly on the design and conduct of trials and highlight other advantages IPD might offer.</AbstractText>
<AbstractText Label="STUDY DESIGN AND SETTING" NlmCategory="METHODS">Potential examples of the impact of IPD meta-analyses on trials were identified at an international workshop, attended by individuals with experience in the conduct of IPD meta-analyses and knowledge of trials in their respective clinical areas. Experts in the field who did not attend were asked to provide any further examples. We then examined relevant trial protocols, publications, and Web sites to verify the impacts of the IPD meta-analyses. A subgroup of workshop attendees sought further examples and identified other aspects of trial design and conduct that may inform IPD meta-analyses.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">We identified 52 examples of IPD meta-analyses thought to have had a direct impact on the design or conduct of trials. After screening relevant trial protocols and publications, we identified 28 instances where IPD meta-analyses had clearly impacted on trials. They have influenced the selection of comparators and participants, sample size calculations, analysis and interpretation of subsequent trials, and the conduct and analysis of ongoing trials, sometimes in ways that would not possible with systematic reviews of aggregate data. We identified additional potential ways that IPD meta-analyses could be used to influence trials.</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">IPD meta-analysis could be better used to inform the design, conduct, analysis, and interpretation of trials.</AbstractText>
<CopyrightInformation>Crown Copyright © 2015. Published by Elsevier Inc. All rights reserved.</CopyrightInformation>
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<AuthorList CompleteYN="Y">
<Author ValidYN="Y">
<LastName>Tierney</LastName>
<ForeName>Jayne F</ForeName>
<Initials>JF</Initials>
<AffiliationInfo>
<Affiliation>MRC Clinical Trials Unit at UCL, Aviation House, 125 Kingsway, London WC2B 6NH, UK. Electronic address: jayne.tierney@ucl.ac.uk.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Pignon</LastName>
<ForeName>Jean-Pierre</ForeName>
<Initials>JP</Initials>
<AffiliationInfo>
<Affiliation>LNCC plateforme de méta-analyse en oncologie, Service de Biostatistique et d'Epidemiologie, Gustave-Roussy, Villejuif, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Gueffyier</LastName>
<ForeName>Francois</ForeName>
<Initials>F</Initials>
<AffiliationInfo>
<Affiliation>Université Claude Bernard Lyon 1/Université de Lyon, 69365 Lyon Cedex 07, Lyon, France; Service de Pharmacologie Clinique, Hospices Civils de Lyon, Bron cedex, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Clarke</LastName>
<ForeName>Mike</ForeName>
<Initials>M</Initials>
<AffiliationInfo>
<Affiliation>All-Ireland Hub for Trials Methodology Research, Queen's University Belfast, University Road, Belfast BT7 1NN, Northern Ireland, UK.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Askie</LastName>
<ForeName>Lisa</ForeName>
<Initials>L</Initials>
<AffiliationInfo>
<Affiliation>NHMRC Clinical Trials Centre, ABN 15 211 513 464, Locked Bag 77, Camperdown, NSW 1450 Australia.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Vale</LastName>
<ForeName>Claire L</ForeName>
<Initials>CL</Initials>
<AffiliationInfo>
<Affiliation>MRC Clinical Trials Unit at UCL, Aviation House, 125 Kingsway, London WC2B 6NH, UK.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Burdett</LastName>
<ForeName>Sarah</ForeName>
<Initials>S</Initials>
<AffiliationInfo>
<Affiliation>MRC Clinical Trials Unit at UCL, Aviation House, 125 Kingsway, London WC2B 6NH, UK.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<CollectiveName>Cochrane IPD Meta-analysis Methods Group</CollectiveName>
</Author>
</AuthorList>
<Language>eng</Language>
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<Grant>
<GrantID>U20</GrantID>
<Agency>Medical Research Council</Agency>
<Country>United Kingdom</Country>
</Grant>
<Grant>
<GrantID>MR/K025635/1</GrantID>
<Agency>Medical Research Council</Agency>
<Country>United Kingdom</Country>
</Grant>
<Grant>
<GrantID>MR/L004933/1</GrantID>
<Agency>Medical Research Council</Agency>
<Country>United Kingdom</Country>
</Grant>
<Grant>
<GrantID>G0800792</GrantID>
<Agency>Medical Research Council</Agency>
<Country>United Kingdom</Country>
</Grant>
<Grant>
<GrantID>G0902303</GrantID>
<Agency>Medical Research Council</Agency>
<Country>United Kingdom</Country>
</Grant>
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<PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType>
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<ArticleDate DateType="Electronic">
<Year>2015</Year>
<Month>06</Month>
<Day>03</Day>
</ArticleDate>
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<Country>United States</Country>
<MedlineTA>J Clin Epidemiol</MedlineTA>
<NlmUniqueID>8801383</NlmUniqueID>
<ISSNLinking>0895-4356</ISSNLinking>
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<CitationSubset>IM</CitationSubset>
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